Recall Z-2063-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
Optical Guidance Platform, version 2.6 and 2.6.1; Reference/FSCA Identifier: CP-03899; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Optical Guidance Platform is for use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions.
| Date | Apr 25, 2011 (initiated Mar 3, 2011) |
| Status | Terminated |
| Reason | The optical guidance platform may not be properly enforcing a 24 hour time limit between optical camera recalibrations. |
| Root cause | Software change control |
| Action | The firm, Varian, sent an "URGENT MEDICAL DEVICE CORRECTION-URGENT FIELD SAFETY NOTICE" letter dated March 3, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately check the Calibration timeout on their optical guidance platform. If this exceeds 24 hour, please set the factory default of 16 hours to ensure that the camera will be calibrated daily. The instructions are located in the document. The customers were also instructed to download the most recent version of the Optical Guidance Platform Instructions for |
| Quantity | 599 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071360 | OPTICAL GUIDANCE PLATFORM Varian Medical Systems, Inc., Jun 8, 2007 |